Description

　　All the benefits and perks you need for you and your family:

　　Benefits from Day One 

　　Paid Days Off from Day One 

　　Student Loan Repayment Program 

　　Career Development  

　　Whole Person Wellbeing Resources 

　　*Our promise to you: *  

　　Joining AdventHealth is about being part of something bigger. It’s about belonging to a community that believes in the wholeness of each person, and serves to uplift others in body, mind, and spirit. AdventHealth is a place where you can thrive professionally, and grow spiritually, by Extending the Healing Ministry of Christ. Where you will be valued for who you are and the unique experiences you bring to our purpose-minded team. All while understanding that together we are even better.  

　　Schedule: Full-time

　　Shift: Day

　　Location: AdventHealth Porter

　　The role you'll contribute:

　　The Clinical Research Coordinator II Non-RN (CRC II Non-RN) serves the AdventHealth Research Institute (AHRI) in the Rocky Mountain Region (RMR). Under limited supervision the CRC II Non-RN is responsible for planning, coordination, evaluation, and performance of nursing care for research participants and collecting data for assigned research projects across multiple locations. The CRC-II (Non-RN) follows study-specific protocol guidelines, communicates with AHRI Principal Investigators (PI), Sub-Investigators (Sub-I), Clinical Research Lead and clinical research support staff. The CRC-II (Non-RN) works to advocate for the patient, while adhering to the conduct of industry-sponsored and investigator-initiated clinical trials in accordance with trial protocols, Food and Drug Administration (FDA) regulations and International Conference on Harmonization/Good Clinical Practices (ICH/GCP) guidelines.

　　Works closely with AHRI Core managers to schedule clinical operations to facilitate the initiation and completion of clinical research studies. Promotes Principal Investigator (PI) oversight by advising the PI, sub-investigator(s), Lead and Director of deviations in conduct, patient status, issues relevant to the integrity of the trial and/or the safety of research subjects; abides by hospital and departmental policies and SOPs, as well as all applicable local, state, and federal regulations.

　　Serves as liaison between Principal Investigators and the Institutional Review Board (IRB) and the Office of Sponsored Programs (OSP). Prepares all documentation for clinical research purposes as may be required by Principal Investigators to track all submissions to IRB and OSP and will meet all reasonable deadlines for submission. Tracks all submissions to IRB and OSP and maintains timely turnaround of all documents to avoid delays in study initiation and/or progress.

　　Actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all.

　　The value you'll bring to the team:

　　Utilizes positive interpersonal communication skills; communicates effectively with members of the healthcare team, patients, investigators, sponsors of research and administration.

　　Reviews all elements of the current institutional IRB approved informed consent (IC) document, according to current FDA, state, federal and institutional regulations with study candidates and/or legal representative; ensures, through patient advocacy and informed consent as an ongoing process, that the rights, safety, and well-being of trial subjects are the most important considerations and should prevail over the interests of science and society.

　　Manages multiple clinical trial protocols, coordinates the execution and follow-up of each protocol, seeks and utilizes resources and works independently; performs accurate, legible and timely documentation. Manages records, study medication and test articles in confidential and secure manner.

　　Promotes Principal Investigator (PI) oversight by advising the PI, sub-investigator(s), Supervisor and/or Clinical Operations Manager of deviations in conduct, patient status, issues relevant to the integrity of the trial and/or the safety of research subjects; abides by hospital and departmental policies and SOPs, as well as all applicable local, state, and federal regulations.

　　Coordinates the work of support staff, laboratory technicians, and assistants to ensure efficient, timely, and high-quality results and adherence to research protocols.

　　Serves as liaison between Principal Investigators and the Institutional Review Board (IRB) and the Office of Sponsored Programs (OSP). Prepares and/or reviews all required documentation for clinical research study start up, execution, modification, renewal, and termination and will meet all reasonable deadlines for submission.

　　Maintains timely turnaround of all documents to avoid delays in study initiation and/or progress. Remains current on rapidly changing regulatory requirements and HIPAA regulations and implements these changes as appropriate and in a timely manner.

　　Collaborates with study sponsors. Assists site monitors during their visits in a professional manner.

　　Works flexible hours and is available as a resource for questions related to research projects.

　　Performs other duties as assigned or directed to ensure smooth and efficient operations of the AHRI and Core. Communicates the need for new work and automatically looks for additional duties as workload permits.

　　Qualifications

　　The expertise and experiences you’ll need to succeed:

　　Required:

　　Bachelor’s degree in healthcare administration, research, or related field and 2 years of experience in clinical research orassociate degree in healthcare administration, research, or related field and 4 years of experience in clinical research or related field or Graduate of an accredited allied health certificate program with six (6) years of clinical research or healthcare experience.Preferred:

　　Master’s degree in healthcare administration, research, or related field.

　　Experience in area of specialty, as assigned.

　　Certified Clinical Research Coordinator (CCRC) (per the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA)

　　Basic Life Support Certificate (BLS), American Heart Association

　　Advanced Cardiovascular Life Support (ACLS)

　　Other certification as applicable to degree or program (i.e. medical assistant, medical technician, phlebotomy)

　　This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances.

　　Category: Research

　　Organization: AdventHealth Porter

　　Schedule: Full-time

　　Shift: 1 - Day

　　Req ID: 24001805

　　We are an equal opportunity employer and do not tolerate discrimination based on race, color, creed, religion, national origin, sex, marital status, age or disability/handicap with respect to recruitment, selection, placement, promotion, wages, benefits and other terms and conditions of employment.